INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS

K100993 · Prismatik Dentalcraft, Inc. · NHA · Dec 28, 2010 · Dental

Device Facts

• Record ID: K100993
• Device Name: INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: NHA · Dental
• Decision Date: Dec 28, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.

Device Story

Inclusive® Titanium Abutments are premanufactured prosthetic components for endosseous dental implants; used to support cemented restorations. Device consists of titanium (Ti-6Al-4V ELI) abutment and screw; connects to implant via internal hexagon interface. Placed by dental professionals in clinical settings. Abutment provides structural support for prosthetic rehabilitation; screw secures abutment to implant. Benefits include restoration of dental function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data. Safety and effectiveness supported by non-clinical bench testing, specifically fatigue testing of worst-case platform samples in accordance with FDA guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Technological Characteristics

Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Design: Endosseous dental implant abutment with internal hexagon connection. Dimensions: Compatible with 3.0, 3.5, 4.0, 4.5, 5.0mm platform diameters. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via cemented restorations supported by Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, or 5.0 endosseous dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Astra Tech AB OsseoSpeed™ Narrow (K081666)
• Astra Tech Implant - Dental System (K990304)
• Astra Tech Implant – Dental System (K931767)

Reference Devices

• Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System

Submission Summary (Full Text)

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K100993

DEC 2 8 2010

# 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

### A. SUBMITTER INFORMATION

| Company Name: | Prismatik Dentalcraft, Inc. |
|------------------------|------------------------------------------------------|
| Company Address: | 4141 Mac Arthur Boulevard<br>Newport Beach, CA 92660 |
| Company Phone: | [phone] |
| Company FAX: | [phone] |
| Contact Person: | Kathleen Dragovich, [phone] |
| Date Summary Prepared: | December 20, 2010 |

### B. DEVICE IDENTIFICATION

| Trade/Proprietary Name: | Inclusive ^® Titanium Abutments for- Astra OsseoSpeed ^™ |
|-------------------------|------------------------------------------------------------------------------|
| | Implants |
| 21 CFR Reference: | 872.3630 |
| 21 CFR Common Name: | Endosseous Dental Implant Abutment |
| Classification: | Class II |
| Panel: | Dental NHA |

### C. IDENTIFICATION OF PREDICATE DEVICE

Astra Tech AB OsseoSpeed™ Narrow, K081666 (10-07-08) Trade/Proprietary Name: Astra Tech Implant - Dental System, K990304 (07-15-99) Astra Tech Implant – Dental System, K931767 (02-08-94)

### D. DEVICE DESCRIPTION

Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the Astra OsseoSpeed™ Implants.

### INDICATIONS FOR USE ن

The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.

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# F. SUBSTANTIAL EQUIVALENCE

The Inclusive® Abutments for Astra OsseoSpeed™ Implants are substantially equivalent to the Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System, and the Astra Tech Implants Dental System Abutments. These abutments are substantially equivalent in intended use, indications for use, material, design and performance.

| Element of<br>Comparison | Prismatik's<br>Inclusive® Abutments for<br>Astra OsseoSpeed™<br>Implants | Astra Tech AB<br>OsseoSpeed™<br>Narrow, K081666 | Astra Tech Implant –<br>Dental System,<br>K990304 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | CP Titanium |
| Platform<br>Diameters<br>(mm) | 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5,<br>5.0mm |
| Indications | The Inclusive® Titanium<br>Abutments for Astra<br>OsseoSpeed™ Implants are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implants and are<br>intended for use as an aid in<br>prosthetic rehabilitation.<br>They are compatible with the<br>Astra Tech OsseoSpeed™ 3.0,<br>3.5, 4.0, 4.5, 5.0 implants. | The Atlantis Abutment is<br>intended for use with an<br>endosseous implant to<br>support a prosthetic device<br>in a partially or completely<br>edentulous patient. It is<br>intended for use to support<br>single and multiple tooth<br>prosthesis, in the maxillary<br>lateral incisors and<br>mandibular lateral and<br>central incisors. The<br>prosthesis can be cement<br>retained to the abutment.<br>The abutment screw is<br>intended to secure the<br>abutment to the<br>endosseous implant. The<br>device is compatible with<br>the Astra Tech OsseoSpeed<br>3.0mm Implant | For use in selected fully<br>edentulous and partially<br>edentulous arches. |
| Design | implant/Abutment assembly<br>with abutment screw.<br>Abutment connection to<br>implant is an internal<br>hexagon. | Implant/Abutment<br>assembly with abutment<br>screw. Abutment<br>connection to implant is an<br>internal hexagon. | Implant/Abutment<br>assembly with abutment<br>screw. Abutment<br>connection to implant is<br>an internal hexagon. |
| Performance | Fatigue testing conducted by<br>Straumann® on stock Astra<br>Tech TiDesign™ abutments<br>and OsseoSpeed™ implants<br>showed mean fatigue<br>strength at 30° was around<br>110N and 125N for the 3.0<br>and 2.5mm implant<br>diameters, respectively. | Fatigue testing conducted<br>at Engineering Materials<br>Laboratory on angled<br>Inclusive® abutments and<br>Astra Tech OsseoSpeed™<br>implants showed mean<br>fatigue strength at 20" was<br>166.8N and 244.7N for the<br>3.0 and 3.5mm implant<br>diameters, respectively.<br>The higher fatigue strength<br>results can be attributed to | |

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### G. PERFORMANCE DATA

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate device.

## H. COMPARISON OF TECHNOLOGICAL DIFFERENCES

There are no known technological differences between the Inclusive® Titanium Abutments for- Astra OsseoSpeed™ Implants and those of the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Kathleen Dragovich Regulatory Affairs Specialist Prismatik Dentalcraft, Incorporated 4141 Mac Arthur Boulevard Newport Beach, California 92660

DEC 2 8 2000

Re: K100993

Trade/Device Name: Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 20, 2010 Received: December 22, 2010

Dear Ms. Dragovich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 - Ms. Dragovich

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT. INC" on the bottom line.

Prismatik Dentalcraft, Inc. 4141 Mac Arthur Boulevard Newport Beach, CA 92660

### INDICATIONS FOR USE STATEMENT

DEC 2 8 2010

510(K) Number: K100993

Device Name: Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants

Indications for Use:

The Inclusive® Titanium Abutments for Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.S. Betz, DDS for Dr. Susan Renner

Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K100993

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